A Phase 1 Study of XL019 in Adults With Polycythemia Vera

This study has been terminated.

Sponsor:

Exelixis

ClinicalTrials.gov Identifier:

NCT00595829

First Posted: January 16, 2008

Last Update Posted: August 21, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

The subject has a diagnosis of polycythemia vera (PV), and has failed, or is intolerant of, standard therapies or refuses to take standard medications.

The subject is ≥18 years old.

The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

The subject has adequate organ function.

Subjects who have received phlebotomy due to PV must have documented phlebotomy history for 12 weeks prior to enrollment.

The subject has the capability of understanding the informed consent document and has signed the informed consent document.

Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.

Female subjects of childbearing potential must have a negative pregnancy test at screening.

The subject has had no other diagnosis of malignancy or evidence of other malignancey for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).

Exclusion Criteria:

The subject has received treatment for PV within 14 days prior to first dose of XL019